Hydromorphone Brand names: Dilaudid; first approved as Dilaudid-Hp

What is hydromorphone used for?

From the label: indications and usage

Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets contain hydromorphone, an opioid agonist, and are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. […]

Conditions named in the indications of hydromorphone's FDA labels, with every medicine labeled for each:

• Pain

FDA pharmacologic class: Opioid Agonist.

Is there a generic for hydromorphone (Dilaudid)?

The FDA approved the first generic hydromorphone on August 23, 1995. 23 generic applications are approved; 14 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists hydromorphone from 13 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists no patent for Dilaudid tablets; a patent listed only for Hydromorphone Hydrochloride injection runs to January 10, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

What do pharmacies pay for hydromorphone (Dilaudid)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.219 per Hydromorphone 4 mg tablet, up 11% from $0.198 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Is hydromorphone in shortage?

The FDA Drug Shortage Database lists 12 of 27 hydromorphone presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on October 31, 2017. 14 more presentations are on the list as available.

Every hydromorphone presentation in the FDA shortage database

Has hydromorphone been recalled?

The FDA's Enforcement Report lists 115 recalls naming hydromorphone since 2012: 4 Class I (the most serious), 110 Class II, 1 Class III; 2 still ongoing. 85 of them are by firms that FDA's NDC Directory does not list as a maker of hydromorphone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

What does the hydromorphone label say about other medicines?

The hydromorphone label names 20 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name hydromorphone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Every other medicine the hydromorphone label names

Other labels that name hydromorphone

• Acetaminophen, butalbital, caffeine and codeine

Check hydromorphone against other medicines

What do FAERS reports show for hydromorphone?

The FDA Adverse Event Reporting System holds 91,453 reports that list hydromorphone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 28,105 are coded as a death and 17,051 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2018 (23,056, against a median of 2,735 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.

Reports received each year

• 2,588
• 3,921
• 23,056
• 2,735
• 8,704
• 17,396
• 15,693
• 2,346
• 2,201
• 1,745
• 719

• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

The most reported reactions

• Drug Dependence35,112
• Overdose (a use or a product term, not a reaction)23,059
• Pain (a use or a product term, not a reaction)22,287
• Emotional Distress17,705
• Death (an outcome recorded in the report)14,911
• Drug Withdrawal Syndrome14,329
• Toxicity To Various Agents10,081
• Nausea (named in the label)4,759

Side effects: the label's list and every FAERS reaction

What else is labeled for the same conditions as hydromorphone?

36 other medicines are given the same way (oral) and in the same FDA class as hydromorphone or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Every medicine labeled for the same conditions as hydromorphone

How does hydromorphone compare with medicines for the same use?

10 side-by-side pages set hydromorphone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

• Codeine
• Hydrocodone
• Ketorolac
• Meperidine
• Methadone
• Morphine
• Naproxen
• Oxycodone
• Oxymorphone
• Tramadol

What next?

Alternatives to hydromorphone

36 medicines for the same use

Other opioids

the pharmacologic class, with prices and generics

Hydromorphone side effects

the label's list beside FAERS reports

Hydromorphone shortage record

every presentation, company and date

Check an interaction

what two or more labels say about each other